Lidocaine as an Adjuvant for Ketamine in Induction of Anesthesia in Septic Shock Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mean arterial pressure
研究概览
简要总结
The aim of the work is to investigate the effect of using lidocaine in combination with low dose ketamine in induction of anesthesia for septic shock patients compared to normal dose of ketamine.
详细描述
Most of the drugs used for induction of anesthesia negatively impact patient hemodynamics. Thus, induction of anesthesia in shocked patients might result in deleterious hypotension. Patients with severe sepsis and septic shock frequently need surgical interventions. The best protocol for induction of anesthesia in septic shock patients is lacking.
Ketamine is an agent used for induction of anesthesia with known positive cardiovascular effects. However, these positive effects were reported in individuals with intact sympathetic nervous system. Invitro studies showed that ketamine direct action on the cardiac muscles is negative. Thus, it had been recommended that ketamine should be used with caution in hemodynamically vulnerable patients till further randomized controlled trials are present.
Lidocaine is a drug with multiple local and systemic uses. Having local anesthetic properties, lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during induction of anesthesia. Lidocaine showed a sparing effect for volatile as well as intravenous requirements for maintenance of anesthesia; thus, we hypothesize that its use as an adjuvant during induction of anesthesia in septic shock patient could provide a sparing effect for ketamine and minimize its negative circulatory sequelae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged above 18 years
- •With septic shock
- •Scheduled for general anesthesia
排除标准
- •Patients under 18 years
- •Burn patients
研究组 & 干预措施
Ketamine group
This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
干预措施: Ketamine full dose (Drug)
Ketamine group
This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
干预措施: Midazolam (Drug)
Ketamine group
This group will receive induction of anesthesia using ketamie full dose 1 mg/kg, midazolam 0.05 mg/Kg, and normal saline 10 mL.
干预措施: Normal saline (Drug)
Lidocaine-ketamine group
This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
干预措施: Ketamine half dose (Drug)
Lidocaine-ketamine group
This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
干预措施: Lidocaine (Drug)
Lidocaine-ketamine group
This group will receive induction of anesthesia using Ketamie half dose 0.5 mg/kg, midazolam 0.05 mg/Kg, and lidocaine 1 mg/Kg.
干预措施: Midazolam (Drug)
结局指标
主要结局
Mean arterial pressure
时间窗: 10 minutes after induction of general anesthesia
Mean arterial pressure measured in mmHg
次要结局
- Heart rate(10 minutes after induction of general anesthesia)
- Cardiac output(10 minutes after induction of general anesthesia)
- The number of patients who suffer from decreased mean arterial pressure by 20% from the baseline reading after induction of anesthesia(10 minutes after induction of general anesthesia)
- Norepinephrine consumption(10 minutes after induction of general anesthesia)
研究者
Ahmed Hasanin
Assistant professor of anesthesia and critical care
Cairo University